MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,ADHESIVE,FABRIC,FINGERTIP,LG,ST

Catalog Number	NON25513
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the "wings" on the bandage don't stay "stuck" to the other part of the bandage as it should.
Additional Manufacturer Narrative
The complaint was received related to a bandage not sticking; the customer reported that the "wings" on the bandage don't stay "stuck" to the other part of the bandage as it should.The samples provided by the customer were evaluated, a coa for the product lot was requested from the vendor, and trend analysis was performed by reviewing the past two years of complaint data; several remaining unopened/unused bandages were inspected for visual defects, none were noted, and after several hours no indication of peeling or weak adhesion was observed.The coa was reviewed and it was determined that the product lot met all technical requirements including adhesive strength; based on the information provided, medline was not able to confirm the reported issue or that the product failed to meet specifications.The documented cause was not confirmed with received sample, and the review of the complaint information as well as the results of the investigation indicated no need for further action.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CURAD
• Common Device Name: BANDAGE,ADHESIVE,FABRIC,FINGERTIP,LG,ST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753411
• Report Number: 1417592-2026-39072
• Device Sequence Number: 18558988
• Product Code: KGX
• UDI-Device Identifier: 10080196740185
• UDI-Public: 10080196740185
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NON25513
• Device Lot Number: 9092400001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown